Home » Other » Training & Certification » Learn "Oracle Clinical/RDC with Project"
icon14.gif  Learn "Oracle Clinical/RDC with Project" [message #607882] Thu, 13 February 2014 00:43
biomedinfo
Messages: 2
Registered: February 2014
Junior Member
./fa/11688/0/BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.

Hands on training will be provided on Oracle Clinical/RDC. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical Research solution providing highly paid Oracle Clinical Jobs in India, USA, UK, as well as other countries.

The focus of the Clinical Data Management training in Oracle Clinical/RDC mainly includes the following topics:

Course Curriculum:
• Introduction to Clinical Research
• Introduction to Clinical Data Management
• Guidelines for CDM
• Roles and Responsibilities of CDM
• Clinical Data Management Process and Life cycle.
• 21 CFR Part 11
• CRF Designing
• Data Capture Methods
• Data Entry
• Data Validation Procedures
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Database Closure and Freezing
• Data Storage & Archival
• Data Coding and Medical Dictionaries
• Quality Assurance & Quality Control
• Auditing
• CDISC Standards

Practical Hands-on Training on Oracle Clinical Database
INTRODUCTION:
• Introduction to OC window
• Subsystems in OC
STUDY PLAN:
• Defining Programs and Projects
• Defining Organization Units
• Defining Regions
• Defining Planned Studies
STUDY DESIGN:
• Easy Study Design
• Creating Intervals
• Creating Events
• Creating Single Regimen treatment
• Creating Investigators and Sites and Assignments
• Creating Patient Positions and Assignment
GLIB:
• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Copy Groups
STUDY DEFINITION:
• Creating DCM's, DCI's & DCI Books
• Validation Procedures
• Derivation Procedures
• Test a Study
• Test Data Entry
DATA ENTRY:
• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrollment
• Missing DCMs
STUDY CONDUCT:
• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Data Extract and SAS Extract
• Making Mass Changes
• Locking and Freezing
LAB:
• Lab Ranges
• Lab Units
• Lab test questions
RDC (Remote Data Capture):
• Data entry in RDC
• Discrepancy Management in RDC
• Study and Site Security

Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
 Web based classroom
 One faculty/student
 Placement support
 Regular/Fast track/Weekend batches
 Flexible timings
 Training Mode: Skype/Teamviewer
 Hands-On Training on the Database

Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman's University-USA and many more...
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.

Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.

Please note that we also provide separate hostel facility assistance for ladies as well as gents.

Contact:

G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
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